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    Summary
    EudraCT Number:2014-004897-40
    Sponsor's Protocol Code Number:GABA-2
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-02-09
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-004897-40
    A.3Full title of the trial
    Randomized, double-blind, placebo controlled, multi-centre, superiority Phase II study to evaluate the safety, pharmacokinetic, efficacy of gabapentin liquid formulation as add-on
    to morphine in children from 3 months to less than 18 years of age experiencing severe chronic neuropathic or mixed pain
    Studio di fase II, randomizzato, in doppio cieco, controllato con placebo, multicentrico, di superiorità, per valutare la sicurezza, la farmacocinetica, l’efficacia di una formulazione liquida di gabapentin in combinazione alla morfina nei bambini di età compresa tra 3 mesi e 18 anni non compiuti con dolore cronico severo di origine neuropatica o mista.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, pharmacokinetic and efficacy study to evaluate the use of gabapentin as additional therapy to morphine in paediatric patients affected by chronic severe pain
    Studio di sicurezza, farmacocinetica ed efficacia per valutare l'uso del gabapentin come terapia aggiuntiva alla morfina in pazienti pediatrici con dolore cronico severo
    A.3.2Name or abbreviated title of the trial where available
    Phase II study to compare efficacy and safety of gabapentin in combination with morphine in children
    Studio di Fase II per confrontare l'efficacia e la sicurezza di gabapentin in combinazione con morfi
    A.4.1Sponsor's protocol code numberGABA-2
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/250/2015
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPHARM - PHARMACEUTICAL RESEARCH MANAGEMENT SRL
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEC,FP7-HEALTH-2013-INNOVATION-1-602962
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPHARM-PHARMACEUTICAL RESEARCH MANAGEMENT srl
    B.5.2Functional name of contact pointTrial Management
    B.5.3 Address:
    B.5.3.1Street Addressvia Einstein
    B.5.3.2Town/ cityCascina Codazza
    B.5.3.3Post code26900- LODI
    B.5.3.4CountryItaly
    B.5.4Telephone number+3903714662684
    B.5.5Fax number+3903714662523
    B.5.6E-mailtrialmanagement@pharmsrl.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namegabapentin
    D.3.2Product code na
    D.3.4Pharmaceutical form Syrup
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGABAPENTIN CLORIDRATO
    D.3.9.1CAS number 60142-95-2
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameGabapentin hydrochloride
    D.3.9.4EV Substance CodeSUB126895
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSyrup
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic pain of neuropathic or mixed origin
    Dolore cronico di origine neuropatica o mista
    E.1.1.1Medical condition in easily understood language
    Chronic pain
    Dolore cronico
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the efficacy of gabapentin as adjunctive therapy to morphine in the treatment of severe chronic neuropathic or mixed pain in children
    from 3 months to less than 18 years of age assessed by the difference in average pain scores between treatment arms at the end of the treatment
    period.
    L'obiettivo primario di questo studio è quello di valutare l'efficacia del gabapentin come terapia aggiuntiva alla morfina per il trattamento del dolore cronico severo di origine neuropatica o mista nei bambini da 3 mesi a meno di 18 anni di età. L’efficacia è misurata come differenza delle valutazioni medie del dolore tra i due trattamenti alla fine del periodo di terapia.
    E.2.2Secondary objectives of the trial
    1.To assess the effect of gabapentin as adjunctive therapy to morphine compared to morphine alone on quality of life (physical, emotional, social and school functioning) and
    global satisfaction with treatment.
    2.To assess the safety of gabapentin combined with morphine compared to morphine alone in the treatment of severe neuropathic or mixed pain
    in children from 3 months to less than 18 years of age.
    3.To characterise the population pharmacokinetic-pharmacodynamic (PKPD) relationship of gabapentin liquid formulation with and without
    morphine and provide confirmation of the recommended paediatric dose.
    Additional exploratory objectives of the study are:
    4.To explore the metabolomic profile of drug treatments.
    5.To explore genetic polymorphisms and their impact on pharmacokinetics (PK) and pharmacodynamics (PD).
    1. Valutare l’effetto del gabapentin come terapia aggiuntiva alla morfina in confronto con la morfina tal quale sulla qualità di vita (fisica, emotiva, sociale e scolastica) e il livello di soddisfazione globale dovuto al trattamento.
    2. Valutare la sicurezza del gabapentin in combinazione con morfina in confronto con la morfina in terapia singola, nel trattamento del dolore cronico severo di origine neuropatica o mista nei
    bambini da 3 mesi a 18 anni di età non compiuti.
    3.Caratterizzare la relazione farmacocinetica-farmacodinamica di popolazione (PK/PD) della formulazione liquida di gabapentin con e senza morfina e fornire la conferma della dose pediatrica raccomandata.
    Obiettivi esplorativi addizionali allo studio sono:
    4. Descrivere il profilo di metabolomica in seguito ai trattamenti farmacologici.
    5. Esplorare i polimorfismi genetici e il loro impatto sulla farmacocinetica (PK) e farmacodinamica (PD).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female, aged 3 months to less than 18 years at screening (V1)
    2.Informed consent by parent(s) and/or legal guardian according to each country legal requirement.
    3.Assent, where applicable, according to each country legal requirement.Informed (co-) consent of child, where applicable, according to each country legal requirement.
    4.Subjects that meet the diagnostic criteria for neuropathic or mixed pain.
    5.Subjects that present with chronic pain defined as the recurrent or continuous pain persisting more than 3 months.
    6.Subject that present with severe pain as defined by average pain intensity of =7 /10 as assessed during a 3-day screening period
    7.Stable underlying disease condition and treatment.
    8.Patients with Chemotherapy Induced Peripheral Neuropathy, when in clinical remission or maintenance phase of their therapeutic protocol.
    1. Soggetti maschio o femmina di età compresa tra i 3 mesi e 18 anni non compiuti alla visita di screening (V1).
    2. Consenso informato da parte dei genitori o del rappresentante legale.
    3. Assenso del paziente, quando applicabile, in accordo con le vigenti leggi locali di ciascun paese.Il (co-) consenso informato del minore, dove applicabile, in base ai requisiti legali di ciascun paese.
    4. Soggetti con criteri diagnostici corrispondenti al dolore di origine neuropatica o mista
    5. Soggetti che presentano dolore cronico definito come il dolore ricorrente o continuo persistente per più di 3 mesi.
    6. Soggetti che presentano un dolore di intensità severa definito dall’intensità media del dolore =7/10, valutata nel periodo di screening di 3 giorni
    7. Condizioni stabili della malattia di base e del trattamento.
    8.Pazienti con neuropatia periferica indotta da chemioterapia, quando in remissione clinica o nella fase di mantenimento del loro protocollo terapeutico
    E.4Principal exclusion criteria
    1.Pain duration of more than 5 years.
    2.Current use of gabapentin.
    3.Current use of strong opioids (morphine, methadone, fentanyl, ketamine, oxycodone).
    4.History of failure to respond to adequate treatment by gabapentin or opioids for neuropathic pain.
    5.History of epileptic condition (except febrile seizure disorder).
    6.Subjects with diagnosis of sickle cell disease.
    7.Subjects that present significant cognitive impairment.
    8.Subjects that present current, controlled or uncontrolled, co-morbid psychiatric diagnosis that can impair pain diagnosis and assessment
    such as severe depressive conditions or psychosis.
    9.Subjects with history of or current suicidal ideation or behaviour.
    10.Subjects with history of substance abuse in particular opioids.
    11.Subjects under prohibited concomitant medication .
    12.Subjects with a body mass index (BMI) for age and gender of < 5th percentile or > 95th percentile (charts provided as Appendix 3).
    13.Subjects with significant renal impairment, i.e., glomerular filtration rate < 90 mL/min/1.73 m2 (Revised Schwarz equation).
    14.Subjects with significant hepatic impairment or with Aspartate Transaminase (AST) or Alanine Transaminase (ALT) enzymes 3 times the
    upper limit of the age-specific reference range.
    15.Subjects in need for corticosteroid oral treatment or corticosteroid infiltrations to treat pain caused by infiltration or compression of neural
    structures, e.g. peripheral nerves or spinal cord.
    16.Subjects with clinically relevant abnormal ECG at the screening visit in the discretion of the Investigator/cardiologist.
    17.Subjects with known allergy, hypersensibility or clinically significant intolerance to gabapentin or any component found in the study drugs.
    18.Subjects with fructose intolerance, diabetes, glucose-galactose malabsorption or lactase-isomaltase deficiency.
    19.Subjects participating in another clinical interventional trial.
    20.Subjects scheduled for surgery or in recovery from surgery occurring within 3 months of baseline assessment.
    21.Female subjects who are pregnant or currently lactating.
    22.Subjects that failed screening or were previously enrolled in this study.
    23.Patients with Chemotherapy Induced Peripheral Neuropathy, when in induction phase of their therapeutic protocol.
    1. Durata del dolore superiore a 5 anni.
    2. Uso corrente di gabapentin
    3. Uso corrente di oppioidi forti (morfina, metadone, fentanil, ketamina, ossicodone).
    4. Pregresso fallimento terapeutico al trattamento con gabapentin o oppioidi per il dolore neuropatico
    5. Pregressa condizione epilettica, ad eccezione delle sole convulsioni febbrili.
    6. Soggetti con diagnosi di anemia falciforme.
    7. Soggetti che presentano significativi deficit cognitivi.
    8.Soggetti che attualmente presentano diagnosi di co-morbidità psichiatriche, controllate o non controllate, che potrebbero compromettere la diagnosi e la valutazione del dolore, come gravi condizioni di depressione o psicosi.
    9. Soggetti con storia pregressa o attuale di ideazioni suicide o comportamenti suicidi.
    10. Soggetti con storia di abuso di sostanze oppioide
    11. Soggetti sottoposti a una terapia concomitante incompatibile con il protocollo di studio (consultare la sezione del protocollo 5.6.3.1 "Farmaci proibiti")
    12. Soggetti con un indice di massa corporea (BMI) <5° percentile o >95° percentile per età e sesso (consultare le tabelle in Appendice 3).
    13. Soggetti con significativa compromissione della funzionalità renale, per es. con velocità di filtrazione glomerulare <90 mL/min/1.73 m2 (equazione di Schwarz).
    14. Soggetti con una significativa compromissione della funzionalità epatica o con livelli enzimatici di aspartato transaminasi (AST) o alanina transaminasi (ALT) 3 volte il limite superiore del range di riferimento specifico per l'età.
    15. Soggetti che necessitano di un trattamento orale con corticosteroidi, o infiltrazioni di corticosteroidi, per il trattamento del dolore causato da infiltrazione o compressione delle strutture nervose, ad esempio dei nervi periferici o del midollo spinale.
    16. Soggetti che presentano un ECG clinicamente anomalo rilevato alla visita di screening (V1), a discrezione del medico sperimentatore/cardiologo.
    17. Soggetti che presentano allergia, ipersensibilità o intolleranza clinicamente significativa al gabapentin o a qualsiasi componente dei farmaci in studio.
    18. Soggetti con intolleranza al fruttosio, con diabete, con malassorbimento di glucosio-galattosio, o con deficienza da lattato-isomaltato.
    19. Soggetti che stanno già partecipando ad un altro studio clinico.
    20. Soggetti che hanno in programma un intervento chirurgico o in convalescenza da un intervento chirurgico avvenuto da meno di 3 mesi dall’analisi basale.
    21. Soggetti femmina gravide o che stanno allattando.
    22. Soggetti che non hanno superato lo screening o che sono stati precedentemente arruolati in questo studio.
    23.Pazienti con neuropatia indotta da chemioterapia, quando nella fase iniziale del loro protocollo terapeutico.
    E.5 End points
    E.5.1Primary end point(s)
    Average pain scores in the two treatment groups (average of 2
    measures each day for 3 days before end of study visit V10) assessed by
    age-appropriate pain scales (FLACC. FPS-R, NRS-11).
    Intensità media del dolore nei due gruppi di trattamento (definita come la media di due misure prese ogni giorno per 3 giorni prima della fine dello studio, alla visita V10) determinata con una scala di valutazione adeguata all’età (FLACC, FPS-R o NRS-11) durante il periodo di ottimizzazione della dose del farmaco
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basale,fine studio
    Baseline, End of study
    E.5.2Secondary end point(s)
    a) Percentage of responders to treatments, defined as subjects with a 30% reduction from baseline in assessment scale (FLACC, FPS-R, NRS-11).
    b) Average daily pain intensity, assessed by age appropriate scale (FLACC, FPS-R or NRS-11) during dose optimization.
    c) Observational assessment of pain using the NRS-11 completed by parents and Investigator (or caregiver) at each visit.
    d) Self-assessment of pain for children =8 years of age using the FPS-R pain scale at each visit.
    e) Extent of pain evaluated as the number of painful areas using the pain charts at screening visit (V1), randomisation (v2) and EOS visit (V10).
    f) Number of episodes of breakthrough pain (>7/10 pain score and use of rescue medications) during treatment period.
    g) Number of rescue interventions required during treatment period.
    h) Number of pain-free days (<4/10 average pain score without the use of rescue medications) during treatment period.
    i) Participant dropouts due to lack of adequate pain response.
    j) The total cumulative weight normalized dose of each rescue drug.
    k) Quality of life, physical, emotional, social and school functioning and quality of sleep on the PedsQL Generic Core Scales (by parent, patient)
    assessed at randomisation (V2) and at EOS (V10).
    l) Acceptability of treatment (Five Point Facial Hedonic Scale) at EOS visit (V10).
    ; m) Global satisfaction with treatment (NRS-11, by parent, patient) at EOS visit (V10). n) Clinical Global Impression of Change (CGI-S, CGI-I; by Investigator) at randomization (V2) for CGI-S and V6 and EOS visit (V10) for CGI-I. o) Patient/parent Global Impression of Change (PGIC; by parent,patient) at V6 and EOS visit (V10). p) Primary (CL/F, Vd/F, Ka) and secondary (AUC, Cmax, Tmax, Css and Cmin) pharmacokinetic parameters for gabapentin. q) Systemic exposure to investigational product during maintenance period, as assessed by predicted steady-state concentrations. r) Incidence of Adverse Events at all visits. s) Percentage of subjects discontinuing the Trial due to treatment emergent adverse events. t) Aggressive behaviour in children aged >6 years using the Retrospective Modified Overt Aggression Scale (R-MOAS) at V2, V6 and EOS visit (V10). u) Suicidal ideation/behaviour in subjects aged 6 years and older using the Columbia - Suicide Severity Rating Scale (C-SSRS) scores before IMP (screening V1), V6, EOS visit (V10) and taper visit (V11). v) Assessment of blinding: guess of the subject's treatment group (by Investigator, parents and subject if at adequate maturity level) at V10
    a) Percentuale dei pazienti che rispondono al trattamento, definita come soggetti con
    riduzione del dolore del 30% rispetto al basale nella scala di valutazione (FLACC, FPS-R, NRS-11).
    b) Intensità del dolore medio giornaliero, valutato in base a una scala di valutazione adeguata all'età (FLACC, FPS-R o NRS-11) durante il periodo dell'ottimizzazione della dose.
    c) Valutazione osservazionale del dolore sulla base della scala NRS-11 compilata dai
    genitori e dal medico sperimentatore (o da un assistente medico) ad ogni visita.
    d) auto-valutazione del dolore per i pazienti =8 anni di età con la scala del dolore FPS-R ad ogni visita.
    e) Intensità del dolore valutato come il numero di zone dolorose usando i grafici del dolore alla visita di screening (V1), randomizzazione (V2) e visita di fine studio (V10).
    f) numero di episodi di dolore intenso (caratterizzati dal punteggio > 7/10 e l'uso di farmaci di supporto durante il periodo di trattamento).
    g) Numero di interventi di soccorso richiesti durante periodo di trattamento.
    h) Numero di giorni senza dolore (caratterizzati da punteggio < 4/10 e senza l’uso della terapia di supporto) durante il periodo di trattamento.
    i) Numero di pazienti ritirati dallo studio per mancanza di un’adeguata risposta al trattamento.
    j) Determinazione della dose totale di ciascun farmaco di supporto normalizzata per il peso del paziente.
    k) Qualità di vita (fisica, emotiva, sociale e scolastica) e qualità del sonno misurate con le scale di misurazione “PedsQL Generic Core Scales” (compilate dai genitori e dai pazienti).
    l) Accettabilità del trattamento valutata con la scala di misurazione “Five-Point Facial Hedonic scale”.
    ; m) Soddisfazione globale rispetto al trattamento (valutazione con scala NRS-11 da parte dei genitori e dei pazienti). n) Impressione globale di cambiamento clinico valutata con le scale di misurazione “CGI-S e CGII”(da parte del medico sperimentatore) alla randomizzazione (V2) per CGI-S e V6 e alla fine dello studio (V10) per CGI-I. o) Impressione globale di cambiamento del paziente valutata con la scala di misurazione PGIC (da parte dei genitori e dei pazienti). p) Determinazione dei parametri farmacocinetici, primari (CL / F, Vd / F, Ka) e secondari (AUC, Cmax, Tmax, Css e C min) di gabapentin. q) Esposizione sistemica al prodotto sperimentale durante il periodo di mantenimento, come determinata in base alle concentrazioni previste allo steady-state. r) Incidenza degli eventi avversi. s) Percentuale di soggetti che hanno interrotto lo studio per eventi avversi dovuti al trattamento. t) Rilevamento di comportamenti aggressivi in bambini con più di 6 anni di età utilizzando la scala di valutazione “Retrospective-Modified Overt Aggression Scale” (R-MOAS). u) Rilevamento di tendenze suicide (ideazione e comportamento suicida) in bambini con più di 6 anni di età utilizzando la scala “Columbia - Suicide Severity Rating Scale” (C-SSRS). v) Valutazione del cieco: determinazione del gruppo di trattamento (da parte dell’Investigatore, dei genitori e del paziente se ha raggiunto un livello di maturità adeguato).
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) Baseline, end of study
    b) Daily during dose optimisation
    c) Monthly
    d) Monthly
    e) Daily during treatment period
    f) Daily during treatment period.
    g) Daily during treatment period.
    h) Daily during treatment period
    i) End of study
    j) End of study
    k) Randomisation, end of study
    l) End of study
    ; m) End of study n) Randomisation, end of optimisation phase, end of study o) End of optimisation phase, end of study p) Sparse sampling during study or end of study q) Sparse sampling during study or end of study r) Monthly s) End of study t) Randomisation, end of optimisation phase, end of study u) Screening, End of optimisation phase, end of study, end of taper v) End of study
    a) basale, fine dello studio
    b) quotidianamente durante l'ottimizzazione della dose
    c) mensile
    d) mensile
    e) quotidianamente durante il periodo di trattamento
    f) quotidianamente durante periodo di trattamento.
    g) quotidianamente durante il periodo di trattamento.
    h) quotidianamente durante il periodo di trattamento
    i) fine dello studio
    j) fine dello studio
    k) randomizzazione, fine dello studio
    l) fine dello studio
    ; m) alla fine dello studio n) alla randomizzazione, alla fine della fase di ottimizzazione, alla fine dello studio o) alla fine della fase di ottimizzazione, alla fine dello studio p) campionamento ridotto durante lo studio o alla fine dello studio q) campionamento ridotto durante lo studio o alla fine dello studio r) mensilmente s) alla fine dello studio t) alla randomizzazione
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Metabolomic
    Metabolomica
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    morfina background therapy
    morphine background therapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Albania
    France
    Germany
    Greece
    Italy
    Netherlands
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 7
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 34
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paediatric Population
    Popolazione pediatrica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 61
    F.4.2.2In the whole clinical trial 66
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    In accordance with the Declaration of Helsinki, subjects who still require analgesic treatment after the study period will be treated with the standard of care practices of the local site and national guidelines-
    In accordo con la Dichiarazione di Helsinki, i soggetti che necessiteranno di trattamento analgesico dopo il periodo di studio saranno
    trattati con le terapie standard disponibili nei centri e secondo le linee guida nazionali.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Teddy Network
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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